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CompletedNCT02853045PRINGENUpdated Sep 24, 2021

Comparison of Blood Pressure Control Achieved in Antihypertensive or Generic Drugs in Moderate to Severe Hypertensive Patients

A Phase 4 interventional study of period with drug (trade name) then period with generic and period with generic then period with drug (trade name) in Hypertension, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 8 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-24.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Phase 4, Interventional, and Other

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jun 2015, registered Jul 2016).
Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Despite a large diffusion for generic anti-hypertensive, they are not currently used.

Clinical validation studies could be better to convince users and prescribers than pharmacologic validation only.

A pragmatic study to evaluate generic anti-hypertensive efficacy is proposed. It takes place in real conditions of care for hypertensive patients, for a manometer control criteria.

The aim of the study is to test the hypothesis of non-inferiority for generic anti-hypertensive for blood pressure control.

Read the detailed description

List of drugs : ALDACTONE, FLUMACH, SPIROCTAN, SPIRONONE, FLUDEX, INDATEN, LASILIX, TENSTATEN, ALDACTAZINE, PRINACTIZIDE, SPIROCTAZINE, MODURETIC, AVLOCARDYL, HEMIPRALON, STHASIN, BETATOP, TENORMINE, CELECTOL, DETENSIEL, FELSAN, KERLONE, RAGON, RONALOL, LOPRESSOR, SELOKEN, NEBILOX, TEMERIT, NEVEROL, SECTRAL, ACUITEL, KOREC, BRIEM, CIBACENE, COVERSYL, CAPTOLANE, LOPRIL, FOZITEC, ODRIK, GOPTEN, PRINIVIL, ZESTRIL, RENITEC, TEOULA, ZOFENIL, TRIATEC, KENOMON, ADALATE, CHRONOADALATE, AMLOR, BAYPRESS, DELTAZEN, DILRENE, DIACOR, MONO TILDIEM, FLODIL, IPERTEN, ISOPTINE, LERCAN, ZANIDIP, LEDELCARBERDIPE, LENIBERCARDIPE, DIBERLEPIDINE, XILERMIS, APROVEL, CRISARTERS, IFIRMASTA, FLUPPE, ZELMIRB, ATACAND, KENZEN, KARBIS, COZAAR, LOBERASNAT, LOTANBERSAR, MICARDIS, PRITOR, TOLURA, ZANACODAR, DINORTES, MIRPRESOC, NISIS, TAREG, CUENCA, TIFIVAL, VAGRECOR, VAMADRID, HYPERIUM, PHYSIOTENS, BIPRETERAX, PRETERAX, LODOZ, WYTENS, ACUILIX, KORETIC, BRIAZIDE, CIBADREX, CAPTEA, ECAZIDE, CORENITEC, ENALAVIS, ENALURETIC, COTRIATEC, RADOUCHE, FOZIRETIC, PRINZIDE, ZESTORETIC, COAPROVEL, IFIRMACOMBI, COCRISARTERS, COKENZEN, HYTACAND, COANHYVA, COHESAN , COTAREG, NISISCO, FORTZAAR, HYZAAR, MICARDISPLUS, PRITORPLUS, MARESSI, TOLUCOMBI, TENORDATE, BETA ADALATE

02

Conditions studied

  • Hypertension

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03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 50 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • hypertensive patient known and treated taking at least two antihypertensive
  • Anti-hypertension treatment available in generic form
  • Absence of changes in the anti-hypertension treatment during the previous 3 months

Exclusion criteria

Exclusion Criteria:

  • Patients on dialysis
  • Patients with cardiac arrhythmia
  • Patient refusing ambulatory blood pressure
05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    period with drug (trade name) then period with generic

    Period of 6 weeks.

    Drug: period with drug (trade name) then period with generic

  • Experimental
    period with generic then period with drug (trade name)

    Period of 6 weeks.

    Drug: period with generic then period with drug (trade name)

Interventions

  • Drugperiod with drug (trade name) then period with generic

    The list of drugs is detailed in the "study description"

  • Drugperiod with generic then period with drug (trade name)

    The list of drugs is detailed in the "study description"

06

What researchers measure

Primary outcomes

  1. Measure of systolic blood pressure

    with holter (ambulatory)

    Time frame: for 24 hours

Secondary outcomes

  1. number of side effects

    number of side effects per patient with a questionnaire

    Time frame: at 12 weeks

07

Study locations

8 sites
  • CH d'ANNONAY
    Annonay, 07100, France
  • CH de FEURS
    Feurs, 42110, France
  • CH de FIRMINY
    Firminy, 42700, France
  • CH du PUY EN VELAY
    Le Puy En Velay, 43000, France
  • CH de MONTBRISON
    Montbrison, 42600, France
  • CH de ROANNE
    Roanne, 42300, France
  • CH de SAINT-CHAMOND
    Saint-chamond, 42400, France
  • CHU de SAINT-ETIENNE
    Saint-etienne, 42000, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02853045
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
Responsible party
Sponsor
First posted
Aug 2, 2016
Start date
Jun 11, 2015
Primary completion
Mar 10, 2021
Completion
Mar 10, 2021
Last update
Sep 24, 2021

Study contacts

Christophe MARIAT, MD PhD
principal investigator · CHU de SAINT-ETIENNE

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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